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Completed

NCT Number: NCT02130258

Somatosensory Profiling in Radicular Pain Patients And it's Correlation With Treatment Outcome

The investigators hypothesize that there may exist different quantitative sensory profiles between radicular pain patients who respond and those who do not respond to the standard therapy of epidural steroid injections (ESI).

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Key information

Conditions

Radiculopathy Lower Extremity Radicular Pain Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MGH Center for Translational Pain Research

Boston, Massachusetts, 02114, United States

About this study

The investigators are comparing warm/cold sensation, heat/cold pain threshold, heat/cold pain tolerance, wind-up, and conditioned pain modulation (CPM) as measured by Quantitative Sensory Testing (QST) between subjects with a radicular pain condition. The investigators are comparing those who respond and those who do not respond to standard therapy (ESI) before and after the treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • diagnosis of lower extremity radicular pain regardless of specific or suspected etiologies
  • scheduling an epidural steroid injection (ESI)

Exclusion criteria

  • a major psychiatric disorder requiring a recent (within one month) hospitalization, such as major depression, bipolar disorder, schizophrenia, anxiety disorder, and psychosis
  • subject is taking illicit or recreational drug detected through a urine toxicology screen
  • subject has had an interventional pain management procedures within the last eight weeks that may alter QST responses including neuraxial or local anesthetic block
  • subject had a change in dosage of neuromodulatory pain medication (including gabapentin, pregabalin, cymbalta, amitriptyline, nortriptyline, trileptal, etc) in the past two weeks
  • subject is pregnant
  • subject has pending litigation involving the current pain condition being treated and studied.

Treatment and study plan

Quantitative Sensory Testing (QST)

Device

Subjects will undergo hot and cold temperature testing using the QST device at two points: 1) Before ESI and 2) after ESI.

Epidural steroid injection (ESI)

Procedure

Subjects will receive an ESI by their clinical physician as part of their clinical treatment. This procedure is not given as part of the research study.

Primary outcomes

  1. Pre-epidural Warm Sensation Quantitative Sensory Testing (QST) Results

    Time frame: Baseline measurement before the epidural injection

    QST tests for changes in spinal nerves. A small metal plate, called a thermode, is placed on the subject's arm. During the warm sensation test, the plate slowly increases in temperature.The subject will stop the test as soon as the plate feels warm. This temperature is recorded and can range from 32-53 degrees Celsius. The same test is repeated on the subject's leg that has radicular pain. The difference in temperatures from the test on the subject's arm and leg were analyzed.

  2. Post-epidural Continued Pain Modulation (CPM)

    Time frame: 4 weeks after the epidural injection

    CPM is a type of QST where the thermode is placed on the subject's non painful arm. Heat stimulation (47 degrees C, 4 seconds) was delivered to the thermode 4 times and the subject rated the pain felt by the heat stimulation on a visual analog scale (VAS) of 0-10. During the second heat stimulation, the subject immersed their hand (opposite from the arm with the thermode) in 12 degree C water and then rated the pain felt by the heat on a VAS of 0-10 (10 is the worst pain a subject can imagine, 0 is no pain). The final 2 heat stimuli were delivered (without using the hand submerged in water). This same test was repeated with the thermode on the subject's leg with radicular pain. The subject placed their hand contralateral to the painful leg in the cold water during the second heat stimulation. The VAS scores from each heat stimulation were averaged for the non-painful arm and the painful leg. The difference in averages between the arm and leg were then analyzed.

  3. Post-epidural Cold Pain Threshold QST Results

    Time frame: 4 weeks after the epidural injection

    The thermode is placed on the subject's arm. During the cold pain threshold test, the plate slowly decreases in temperature.The subject will stop the test when the plate is at their minimal tolerable temperature. This temperature is recorded and can range from 32-0 degrees Celsius. The same test is repeated on the subject's leg that has radicular pain. The difference in temperatures from the test on the subject's arm and leg were analyzed.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Important dates

Study start
2012
Primary completion
2016
Study completion
2017
First posted
May 5, 2014
Registry last updated
Feb 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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